Protecting the Public s Health: Critical Functions of the Section 317 Immunization Program A Report of the National Vaccine Advisory Committee

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78 Public Health Reports / March–April 2013 / Volume 128

Protecting the Public’s Health:

Critical Functions of the Section 317

Immunization Program—A Report of the

National Vaccine Advisory Committee

Vaccines are one of our most successful tools for protecting the public’s health. It seems simple: a pharmaceutical company develops a new vaccine, the U.S. Food and Drug Administration (FDA) licenses it, health-care providers give it to their patients, and we see disease disappear. But vaccination in the United States is much more complex and only made possible through a robust public-private partnership that begins with the development of the vaccine and continues long after it is used routinely. Along every step of the way, public health—at the national, state, and local levels—plays a fundamental role. The success of the pneumococcal conjugate vaccine (PCV) in preventing suffering, disability, and death is one example that illustrates the essential role of our nation’s public health systems and workforce in protecting us from vaccine-preventable diseases (VPDs).

Streptococcus pneumoniae (pneumococcus) is a major cause of invasive disease, including meningitis, pneumonia, and bacteremia. In the absence of a pedi-atric vaccine, pneumococcus was a significant public health concern, causing approximately 63,000 cases of invasive pneumococcal disease and 6,100 deaths in the U.S. each year.1 Young children and older adults are especially vulner-able, and many children who develop pneumococcal meningitis have long-term complications such as deafness or seizures.

In 2000, a pediatric heptavalent PCV (PCV7) was licensed for use in the U.S. There are more than 90 strains of pneumococcal bacteria, and PCV7 provided protection against seven of them. Before PCV7 was introduced, these seven strains caused more than 80% of severe pneumococcal infections among children.2

Most health-care providers in the U.S. look to public health for guidance in the use of vaccines. After a careful review of the evidence, including data about the burden of disease caused by pneumococcus, the effectiveness and safety of the vaccine, and the feasibility of incorporating it into the immuni-zation program, the Advisory Committee on Immuniimmuni-zation Practices (ACIP) made a recommendation for the routine use of PCV7 among children,2 and the Centers for Disease Control and Prevention (CDC) incorporated it into the immunization schedule, which gives doctors specific recommendations for the use of vaccines across the life span.

Public health helps inform people about the vaccines they need and the risks and benefits of receiving vaccines. Parents consider many factors when decid-ing to vaccinate their children. Usdecid-ing science-based strategies, public health provided parents with information about the risks of pneumococcal disease and the benefits of the new vaccine. State and local public health experts worked with the health-care providers in their communities to make sure they had the National Vaccine Advisory

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tools they need to help their patients make informed decisions, from how to hold a child during a vaccina-tion to responding to quesvaccina-tions about the need for, and the safety of, the vaccine.

Vaccine supply interruptions are managed by public health to ensure that those most at risk can be pro-tected first. Following the 2000 recommendation, the supply of PCV7 vaccine did not keep up with demand.3 Because some children are at higher risk of disease and/or its complications than others, public health was called upon to help conserve vaccine and direct it to protect those children at highest risk. CDC issued interim vaccination recommendations to withhold vaccine from healthy children aged 2 years and older, and to defer some doses for healthy children who were younger than 2 years of age.4 Public health experts and systems at the state and local levels provided strategies for implementing the vaccination guidelines, such as using immunization registries to identify those children who need to be vaccinated and issuing reminders to parents to get them vaccinated.

Public health continued to monitor the supply of PCV7 and, in 2004, when the supply stabilized, public health terminated the interim recommendations so that the vaccine could be used according to the 2000 recommendation.5

Public health evaluates our national vaccine pro-grams and policies. Post-licensure evaluation of vac-cine performance is necessary to ensure that vacvac-cines have the intended public health impact. In the first five years that PCV7 was used, the incidence of inva-sive pneumococcal disease in children fell by 94%.6 In addition to the protection provided to vaccinated children, the work done by our public health systems and experts demonstrated that the vaccine also sig-nificantly reduced transmission of pneumococcus to unvaccinated people, including adults. Public health data from Active Bacterial Core surveillance (ABCs) showed a more than 90% decrease in the rate of invasive pneumococcal disease caused by the vaccine serotype disease among people aged 5 years and older, with a dramatic decrease in disease among adults 65 years of age and older.6 In addition to impressive reductions in disease, economic analyses conducted by CDC showed that every $1 invested in PCV7 resulted in a cost savings of $1.50.7 This type of information informs our national strategies for preventing invasive pneumococcal disease, including the best investment of health-care resources.

Public health data are critical to the development of new and better vaccines.Over time, public health’s pneumococcal surveillance showed that while there were significant reductions in disease caused by the

pneumococcus serotypes prevented by PCV7, there were increases in invasive disease caused by non-vaccine serotypes. This finding prompted vaccine manufactur-ers to develop a new vaccine and, in 2010, the FDA

National Vaccine Advisory Committee Chair

Walter A. Orenstein, MD, Emory University, Atlanta, GA

Designated Federal Official

Bruce G. Gellin, MD, MPH, National Vaccine Program Office, U.S. Department of Health and Human Services, Washington, DC

Public Members

Richard H. Beigi, MD, MSc, Magee-Womens Hospital, Pittsburgh, PA

Tawny Buck, Missoula, MT Sarah Despres, JD, Washington, DC

Philip S. LaRussa, MD, Columbia University, Department of Pediatrics, New York, NY

Ruth Lynfield, MD, Minnesota Department of Health, St. Paul, MN

Yvonne Maldonado, MD, Stanford University, Stanford, CA Julie Morita, MD, Chicago Department of Public Health,

Chicago, IL

Charles Mouton, MD, MS, Meharry Medical College, Nashville, TN

Amy Pisani, MS, Every Child by Two, Mystic, CT

Mitchel C. Rothholz, RPh, MBA, American Pharmacists Association, Alexandria, VA

Thomas E. Stenvig, RN, PhD, MS, South Dakota State Uni-versity College of Nursing, Brookings, SD

Litjen (LJ) Tan, PhD, MS, American Medical Association, Chicago, IL (current affiliation: Immunization Action Coalition, St. Paul, MN)

Catherine Torres, MD, State of New Mexico, Santa Fe, NM Kasisomayajula Viswanath, PhD, Harvard School of Public

Health, Boston, MA

Representative Members

Seth Hetherington, MD, Genocea Biosciences, Cambridge, MA

Clement Lewin, PhD, MBA, Novartis Vaccines and Diagnostics, Cambridge, MA

Liaison Representatives

Anne Bailowitz, MD, MPH, National Association of County and City Health Officials, Baltimore, MD

Carol Baker, MD, Centers for Disease Control and Preven-tion, Advisory Committee on Immunization Practices, Houston, TX

Robert S. Daum, MD, CM, U.S. Food and Drug Administra-tion, Vaccines and Related Biologics Products Advisory Committee, Chicago, IL

Charlene Douglas, PhD, MPH, RN, Advisory Committee on Childhood Vaccines, Fairfax, VA

Claire Hannan, MPH, Association of Immunization Manag-ers, Rockville, MD

Paul Jarris, MD, MBA, Association of State and Territorial Health Officials, Arlington, VA

Wayne Rawlins, MD, MBA, America’s Health Insurance Plans, Hartford, CT

Vesta Richardson, MD, Health Ministry of Mexico, Mexico City, Mexico

David Salisbury, CB, FRCP, FRCPCH, FFPHM, United King-dom, Department of Health, London, UK

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licensed PCV13, which provides protection against six additional serotypes. In particular, PCV13 protects against serotype 19A, which was not covered in PCV7 and which had become the most common pneumo-coccal serotype. Another important benefit of PCV13 is that S. pneumoniae of serotype 19A is often resistant to antibiotics.

Following the recommendation for routine use of PCV13,8 public health systems and experts at the national, state, and local levels have worked with health-care providers to incorporate this new vaccine into the childhood schedule. This change included guidance for transitioning the use of PCV7 to PCV13, and monitoring vaccine coverage and the incidence of pneumococcal disease caused by the 13 strains in the new vaccine.9

A decade after licensure of the first generation of PCV, the story continues. In 2011, PCV13 was licensed for use among adults aged 50 years and older. In June 2012, the ACIP voted to recommend that adults at very high risk due to immunocompromising conditions be vaccinated with PCV13. While PCV13 may prove to be an effective tool for protecting adults from pneumococ-cal disease, the ACIP is awaiting more data on vaccine efficacy and more information about the indirect pro-tection vaccinating children provides to unvaccinated adults before making a recommendation for routine use of PCV13 in adults.10 Our public health systems and experts will continue to track the use of PCV13 in the U.S., monitor the vaccine’s effectiveness and safety, and gauge its impact on pneumococcal disease among all age groups. This information is essential to inform sound national strategies to prevent pneumococcal disease and guide decisions for investing health-care resources.

Public health infrastructure is fundamental to the provision and execution of public health services at all levels. A strong infrastructure provides the capacity to prepare for and respond to both acute (emergency) and chronic (ongoing) threats to the nation’s health. Infrastructure is the foundation for planning, deliver-ing, and evaluating public health.

INtRoduCtIoN

The achievements of our national immunization pro-gram are impressive. Today, we have recommendations for the routine use of vaccines to prevent 17 VPDs. We enjoy record-high immunization coverage rates, most VPDs are at or near record lows, and a majority of diseases are showing a 90% or higher decline in reported cases when compared with the pre-vaccine era.11 Immunization continues to be one of the most

National Vaccine Advisory Committee (continued)

Federal Ex Officio Members

Matthew Burke, MD, Health Resources and Services Administration, Rockville, MD

Richard Church, PharmD, Indian Health Service, Rockville, MD

Geoffrey Evans, MD, Health Resources and Services Administration, Rockville, MD

Marion Gruber, PhD, U.S. Food and Drug Administration, Rockville, MD

Iris Mabry-Hernandez, MD, MPH, Agency for Healthcare Research and Quality, Rockville, MD

Rick Hill, DVM, MS, U.S. Department of Agriculture, Ames, IA Jeffrey A. Kelman, MD, MMSc, Centers for Medicare and

Medicaid Services, Washington, DC

Richard Martinello, MD, U.S. Department of Veterans Affairs, West Haven, CT

Margaret McCluskey, RN, MPH, U.S. Agency for International Development, Washington, DC

Barbara Mulach, PhD, National Institutes of Health, Bethesda, MD

Anne Schuchat, MD, Centers for Disease Control and Preven-tion, Atlanta, GA

COL Scott A. Stanek, DO, MPH, U.S. Department of Defense, Washington, DC

National Vaccine Advisory Committee Immunization Infrastructure Working Group

Anne Bailowitz, MD, MPH, National Association of County and City Health Officials, Baltimore, MD

Terry L. Dwelle, MD, MPHTM, FAAP, CPH, Association of State and Territorial Health Officials, Bismark, ND Paul Etkind, DrPH, National Association of County and City

Health Officials, Washington, DC

Mark Grabowsky, MD, MPH, National Vaccine Program Office, U.S. Department of Health and Human Services, Washington, DC

Amy Groom, MPH, Indian Health Service, Albuquerque, NM Claire Hannan, MPH, Association of Immunization

Manag-ers, Rockville, MD

Clement Lewin, PhD, MBA, Novartis Vaccines and Diagnostics, Cambridge, MA

Julie Morita, MD, Chicago Department of Public Health, Chicago, IL

Charles Mouton, MD, MS, Meharry Medical College, Nashville, TN

Walter Orenstein, MD, Emory University, Atlanta, GA [NVAC Chair]

Amy Pisani, MS, Every Child By Two, Mystic, CT

Kristin Pope, MEd, Centers for Disease Control and Preven-tion, Atlanta, GA

Angela K. Shen, ScD, MPH, National Vaccine Program Office, Washington, DC [Current affiliation: U.S. Agency for Inter-national Development, Washington, DC]

Candice Swartwood, MPH, Centers for Disease Control and Prevention, Atlanta, GA

Kathy Talkington, MPH, Association of State and Territorial Health Officials, Washington, DC

Litjen (LJ) Tan, PhD, MS, American Medical Association, Chicago, IL [NVAC Immunization Infrastructure Working Group Co-Chair] (current affiliation: Immunization Action Coalition, St. Paul, MN)

Catherine Torres, MD, State of New Mexico, Santa Fe, NM [NVAC Immunization Infrastructure Working Group Co-Chair]

Melinda Wharton, MD, Centers for Disease Control and Prevention, Atlanta, GA

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impactful and cost-effective public health interventions. For each birth cohort vaccinated against 13 diseases in accordance with the routine childhood immuniza-tion schedule, $13.6 billion in direct medical costs and 42,000 lives are saved, and 20 million cases of disease are prevented.7

The success of our national childhood immunization program rests on a robust public-private partnership. Public health, with unique roles at the national, tribal, state, and local levels, has built the foundation of an immunization system that ensures that our immuniza-tion policies and programs promote equitable access to safe and effective vaccines, regardless of whether or not a vaccine is publicly or privately purchased, particularly for the pediatric population.

Purchasing and administering vaccine is only a small piece of the entire enterprise, however, as illustrated by the aforementioned pneumococcal story. A strong immunization system also requires a stable infrastruc-ture from the federal to the local levels that includes a highly trained immunization workforce, disease surveillance experts and systems, scientific support for developing immunization policies, systems for moni-toring and assuring vaccine safety, and mechanisms to monitor vaccine coverage rates.

In the past decade, we have also seen several changes that present both new opportunities and challenges to the immunization system. The number of lifesaving vaccines available has increased dramatically, while the cost of vaccines has also risen. The passage of the Affordable Care Act (ACA)12,13 has the potential to provide unprecedented access to vaccines by increas-ing the number of people insured and, thus, covered for vaccination, as well as removing copayments for these people, thereby incentivizing administration and receipt of the vaccines. As expanded health coverage is fully realized, greater numbers of children and adults will gain access to vaccines through public and private health insurance. However, as we have learned over the years, insurance coverage alone is not enough to ensure disease control or high vaccination coverage rates. It will be necessary to maintain a strong public health infrastructure to support the U.S. vaccination program. Current vaccine financing strategies, includ-ing those offered now by the ACA, do not address the fundamental resource needs to support the immuniza-tion infrastructure. With these many changes since the enactment of the Section 317 Immunization Program, the National Vaccine Advisory Committee (NVAC) feels that this is an ideal and indeed critical time to reexam-ine and strengthen the immunization infrastructure.

tHe SeCtIoN 317 ImmuNIzAtIoN PRogRAm A key resource in support of establishing and main-taining the public health immunization infrastructure is the contribution of the Section 317 Immunization Program.14 The Section 317 Program, administered by CDC, was enacted in 1962 through the Vaccine Assis-tance Act, or Section 317 of the Public Health Service Act. During its 50-year history, the Section 317 Program has played a critical role in helping to achieve national immunization goals by addressing unmet needs and supporting efforts to plan, develop, and maintain an immunization infrastructure necessary to ensure high vaccination coverage levels and low incidence of VPDs. A profound strength of the program is its flexibility, allowing it to respond efficiently and effectively to state-specific priorities and unexpected outbreaks of disease. Initially designed to purchase polio, diphtheria, pertussis, tetanus, and smallpox vaccines, with measles vaccines added in 1965, the Section 317 Program has evolved with the introduction of new vaccines and immunization recommendations and the changing health-care landscape to become much more than a vaccine purchase program. However, the Section 317 Program is a discretionary program; therefore, funding is set through the annual appropriations process and is not guaranteed from year to year.

As with all discretionary programs, the President submits the budget request each year to Congress for the following fiscal year, as required by the Budget and Accounting Act of 1921.15 The President’s budget request outlines the administration’s intended spend-ing and is developed through an iterative process in which agencies and operating divisions present pro-posed funding levels for consideration, with the Office of Management and Budget setting a final spending level that is included in the President’s budget request. Ultimately, discretionary spending is determined through negotiations between the House and Senate Appropriations Committees and their various subcom-mittees. They may or may not use the levels requested in the President’s annual budget.

The Section 317 Program helps protect all Ameri-cans from VPDs by providing the backbone of the U.S. immunization program—regardless of the payer for the vaccine given—by ensuring that vaccines are accessible, safe, effective, and used most successfully to protect the nation’s health. The Section 317 Program provides the majority of federal support for national, state, and local immunization systems and the workforce necessary to implement a comprehensive immunization program (Figure 1) through:

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• Immunization infrastructure grants: funds

awarded to 64 immunization programs (all 50 states, the District of Columbia, five large cit-ies, five U.S. territorcit-ies, and three Pacific freely associated states) to support immunization work-force and systems at the state and local levels to recruit and educate networks of immunization providers, provide continual quality assurance, promote public awareness of new and expanded vaccine recommendations, manage vaccine short-ages, and prepare for and respond to vaccine- preventable outbreaks.

• Vaccine purchase: federally purchased vaccines

allocated to the 64 immunization programs to protect non-Vaccines for Children (VFC) Program-eligible populations with routinely rec-ommended vaccines, and to meet urgent needs such as responding to VPD outbreaks. Unlike VFC Program vaccines, for which there are very specific eligibility criteria, Section 317 vaccines can be used to rapidly protect all members of a community when VPD outbreaks occur.

• Extramural program operations: contributes to

the systems and workforce that conduct disease surveillance, assess vaccination coverage, perform post-marketing evaluation of vaccine effectiveness and safety, develop and implement immunization

information technologies, support centralized vaccine ordering and distribution systems, and create and implement public awareness cam-paigns and resources, as well as provider educa-tion and tools.

• National program operations: provides national

public health expertise in VPDs that supports national, state, and local vaccination program efforts, including expertise in epidemiology and surveillance, laboratory methods and science, immunology, immunization policy, health com-munications science, vaccine management, and program implementation.

During the past decade, appropriations to the Sec-tion 317 Program have stagnated at levels that are insufficient to maintain this important work. Most recently, as the annual appropriation to the Section 317 Program has eroded, gaps in support for these important activities have been funded through the Prevention and Public Health Fund (PPHF), which was established through the ACA. The PPHF has proven a valuable resource for strengthening immunization systems and workforce at the national, state, and local levels. However, the instability of this funding source poses risks as it funds a larger proportion of the Sec-tion 317 Program (Figure 2).

Figure 1. Section 317 Immunization Program, fiscal year 2012:

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tHe NAtIoNAl VACCINe AdVISoRy CommIttee

The NVAC is a federal advisory committee, established in 1987, that provides vaccine and immunization advice and policy recommendations to the Director of the National Vaccine Program (NVP). The Assistant Sec-retary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the NVP.14 The NVAC recommends ways to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. Spe-cifically, the NVAC was chartered, through the Public Health Service Act, with four main responsibilities:

• Study and recommend ways to encourage the

availability of an adequate supply of safe and effective vaccination products in the U.S.

• Recommend research priorities and other mea -sures that should be taken to enhance the safety and efficacy of vaccines.

• Advise the ASH on the implementation of the

NVP’s responsibilities and the National Vaccine Plan, a coordinated, strategic framework estab-lished to achieve the vision of the NVP.

• Identify the most important areas of government

and nongovernment cooperation that should be considered in implementing the NVP’s responsi-bilities and the National Vaccine Plan.16

In 2011, the NVAC identified the need to describe the nation’s public health immunization infrastructure and to explore policy options to assure the stability of that infrastructure through the Section 317 Program in the changing health-care landscape. Increases in Sec-tion 317 funding have been positively and significantly associated with increases in vaccination coverage.17 A Working Group on Immunization Infrastructure was appointed by the chairman of the NVAC to describe critical functions of immunization programs at the national, state, tribal, and local levels, and included representatives from federal agencies, professional organizations, consumer groups, individuals in vaccine research or with manufacturing experience, state and local health departments, and academic centers. This report contains NVAC recommendations based on the Working Group’s findings and conclusions. The overall goal of the report is to describe the essential public health functions supported by the Section 317 Program (Figure 3) and to examine and recommend strategies that maintain these functions, while encouraging public health at the national, state, and local levels to adapt

Figure 2. Federal immunization funding: Section 317 Immunization Program appropriation and Prevention and Public Health Funds

PPHF 5 Prevention and Public Health Fund

Section 317 appropriation PPHF allocation

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and evolve to meet these new challenges and oppor-tunities toward protecting all Americans from VPDs. deVeloPINg eVIdeNCe-BASed

ImmuNIzAtIoN PolICy

In the U.S., the ACIP advises CDC on national vaccine policy for preventing infectious diseases in the civilian population. Once adopted by CDC, the Committee’s recommendations establish the standard of practice for preventing VPDs and, as of September 2010, deter-mine the vaccines that must be covered without cost to vaccine recipients by private health insurance plans.18

Comprising 15 voting members with expertise in medicine and public health along with a consumer representative, the Committee holds public meetings three times a year to make its vaccine recommenda-tions. The members consider the approved indications for vaccines, principles of equity and social justice, and the evidence base for use of a given vaccine among the U.S. civilian populations. The immunization systems and expertise that are supported by the Section 317 Program make substantial contributions to the evidence base upon which the ACIP deliberates in making its recommendations. They do so by providing data about the burden of disease that can be prevented, about the safety and efficacy of the vaccine, and by supplying economic analyses (including cost-effectiveness data) in addition to information about other factors, such as

how an ACIP recommendation can be implemented by the health-care system in conjunction with other recom-mended vaccines. The Committee’s recommendations provide guidance on the population to be vaccinated; the appropriate route, dose, and frequency of vaccine administration; and information about contraindica-tions and precaucontraindica-tions, as well as recognized adverse events. Once the Committee’s recommendations are accepted by the CDC Director, they are published in the Morbidity and Mortality Weekly Report.

Each year, the individual vaccination recommenda-tions are summarized in immunization schedules for children, adolescents, and adults. The immunization schedule provides a roadmap for health-care provid-ers about all of the vaccines recommended for their patients. To reduce confusion and proliferation of different recommendations, public health collaborates in developing its schedules with the medical associa-tions whose members provide vaccines, including the American Academy of Pediatrics, the American Acad-emy of Family Physicians, the American College of Physicians, and the American College of Obstetricians and Gynecologists.

The ACIP continues to review the safety and effec-tiveness of vaccines even after the vaccines are rec-ommended, and adjustments may be made as more data become available. New data are reviewed in the context of the risks of adverse effects and the benefits provided by the vaccine. For example, when polio was

Figure 3. Role of Section 317 Immunization Program funding in preventing infectious disease

Section 317

funding

Critical functions of immunization programs develop evidence-based immunization policy

Communicate which vaccines are needed, and the benefits and risks

Improve access to immunization servicesa

Assure quality immunization services

Assess vaccine effectiveness and safety monitor program performance Respond to public health emergenciesa

High

vaccine

coverage

rates

Healthy

population

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more prevalent globally, the U.S. primarily used oral polio vaccine (OPV) to protect Americans from the risk of imported cases because it was perceived to be more effective at reducing the transmission of disease, even though it was associated with a risk of vaccine-associated poliomyelitis of one in 750,000 first doses.19 As global polio control improved and the risk of polio importations into the U.S. decreased, the risk-benefit of use of OPV was reevaluated. In 2000, the ACIP rec-ommended that OPV be replaced with the inactivated polio vaccine, which has no risk of vaccine-associated paralytic disease.

Immunization policies are also made at the state and local levels, and many states have immunization advisory committees that provide advice. State and local policies can significantly impact the health of their jurisdictions, and public health systems and expertise supported by the Section 317 Program provide impor-tant evidence and data to inform those decisions. State and local policies are most often focused on vaccina-tion requirements for day care and school entry, and on vaccinating personnel and patients in health-care settings. Immunization requirements reinforce clinical recommendations for vaccination and are an important tool for improving and maintaining high vaccination coverage. For example, state and local vaccination requirements for school entry have been shown to increase vaccination coverage among elementary schoolchildren, and more recently have been shown to increase coverage for some adolescent vaccinations.20 CommuNICAtINg VACCINe

ReCommeNdAtIoNS ANd tHeIR BeNeFItS ANd RISkS

In the U.S., we enjoy the benefits of vaccination rec-ommendations across the life span, from infancy to old age. Public health plays an important role at the national, tribal, state, and local levels in making the public aware of the vaccines that are recommended for them. Communication specialists apply communication science and best practices to create materials and tools to improve the public’s awareness about the vaccines that are available to and recommended for them. The Section 317 Program contributes to this science base and supports efforts to deliver information about the risks of VPDs, the benefits of immunization, and any known side effects of vaccination using various formats, channels, and trusted spokespeople who resonate with the target audience’s values and beliefs.

By protecting myself, I am protecting her

Section 317 has contributed to the public health com-munications research that has found that different

groups view the benefits of vaccination differently. Using these findings, materials have been developed that focus on the benefits that a particular group values most. For example, older adults, who are at increased risk of seasonal influenza, value their ability to protect their loved ones more so than protecting themselves from influenza. Based on these findings, public health promotes the influenza vaccination to seniors as the best way to protect themselves and those they love from the flu.

Informed patients make the best decisions for themselves and their families. As with any medical intervention, most patients have questions about vaccines—why they are needed, if they are effective, and if they are safe—and health-care providers are an important and trusted source for answers to these questions. Public health works with medical associations and other partners to develop resources and tools for health-care providers and their patients to inform their decisions about vaccines. The Section 317 Program supports national, state, and local efforts to educate health-care providers through multiple formats and venues about evidence-based strategies and techniques for answering questions about vaccine effectiveness, safety, and the diseases they prevent, as well as advising the public on the vaccines they need for themselves and their children.

ImPRoVINg ACCeSS to ImmuNIzAtIoN SeRVICeS

In the U.S., immunization services, especially for chil-dren, are provided primarily in the medical home. However, vaccines are also offered in many other settings, such as public health clinics and commu-nity health centers, and complementary venues such as pharmacies, retail clinics, and schools. With the expansion of routinely recommended vaccines for adolescents and adults, medical specialties other than pediatrics and family medicine play an increasingly important role in providing access to immunization services.

The Section 317 Program plays an important role in supporting the immunization systems and workforce that recruit and train robust networks of vaccine pro-viders by building strong partnerships at the national, state, tribal, and local levels to ensure that vaccines are accessible, regardless of the individual’s insur-ance coverage. Public health works with associations representing public and private health-care providers, vaccine manufacturers, and health insurance plans to identify strategies to recruit and train networks of vaccine providers so that there is adequate access to VFC Program21 providers in every community, and

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access to in-network providers for those with insur-ance. It is important to recognize that while the VFC Program provides vaccine at no cost to eligible children and adolescents, the significant achievements of the VFC Program in improving vaccination coverage and eliminating disparities would not be possible without the immunization infrastructure supported by the Section 317 Program.22 Public health promotes the use of proven strategies to improve vaccination cover-age among children, adolescents, and adults through resource materials, trainings, and visits to clinical sites. The Section 317 Program has been an essential resource for developing, evaluating, and promoting evidence-based public health tools,23 which include:

• AFIX (assessment, feedback, incentives,

eXchange), which incorporates four key strate-gies proven reliable to improve providers’ immu-nization service delivery and raise vaccination coverage levels;

• Standing orders for vaccinations, which stipu -late that all people meeting certain eligibility requirements should be vaccinated, thus elimi-nating the need for individual physician’s orders for each patient; and

• Reminder and recall systems that alert

health-care providers and patients that the patient is due or overdue for vaccination. Immunization information systems (IISs) and electronic health records (EHRs) can facilitate automation of reminder-recall systems.

ASSuRINg tHe quAlIty oF ImmuNIzAtIoN SeRVICeS

Quality assurance for vaccine delivery and immuniza-tion practice is an important public health funcimmuniza-tion. State and local public health systems and workforces that are supported in part by the Section 317 Program give health-care providers ongoing training and techni-cal assistance to support their vaccination programs. Public health experts visit clinical offices to assure appropriate vaccine storage and handling practices, and to identify opportunities to improve vaccination coverage among their patients. However, the resources required to establish public-private collaborations to fully support and improve practice for immunization across the life span are currently not sufficient and, as a result, efforts in adult immunization have lagged behind those in pediatrics.24 Thus, while the Section 317 Program is authorized to support adult immuniza-tion efforts, historically the funds appropriated have been inadequate to do so.

Vaccines need to be stored in the right equipment

at the right temperature to ensure the most protection. The Section 317 Program supports efforts to improve storage and handling practices at the provider office. For example, in California, the Section 317 Program supports the California Department of Public Health’s effort to provide training and resources for health-care providers to help them effectively store and manage their vaccine inventory. This maintenance includes eas-ily accessible Web-based materials,25 such as the EZIZ Online Immunization Skills Curriculum on storing vaccines, monitoring refrigerator temperatures, and monitoring freezer temperatures; and Vaccine Storage and Handling Job Aids for refrigerator and freezer setup, monitoring temperatures, transporting vaccines, and managing vaccine inventory.

State and local public health officials assist providers with response to vaccine administration errors (e.g., what to do when a vaccine is administered subcutane-ously instead of intramuscularly) and management of vaccine stocks that have been exposed to temperature conditions outside the recommended range. These important public health functions are also partly funded through the Section 317 Program.

Finally, information technology plays an important role in immunization program management and imple-mentation by improving the quality of immunization data and enhancing accountability and stewardship of public vaccine resources. IISs are now a critical part of immunization programs, ensuring that individuals get the vaccines they need when they need them. The Section 317 Program is a critical resource for assuring that immunization technologies support the integra-tion of quality immunizaintegra-tion services into clinical preventive care. The Section 317 Program contributes to the efforts to improve the interoperability of these public health systems with other health-care systems to enhance the completeness, timeliness, and exchange of data across systems. Interoperability of IISs with EHRs will make it easier for health-care providers to report and receive data about their patients’ immunization status from state or local IISs, ultimately making the determination of a patient’s vaccination needs routine. IISs can also provide vaccine inventory tracking and are now being integrated with the national vaccine ordering and tracking system for vaccines purchased from CDC vaccine contracts, linking information about vaccines administered with vaccine ordering and dis-tribution data. Other efforts to advance improvements in data quality include the addition of two-dimensional barcoding to vaccine packaging, which will allow provid-ers to scan vaccine information into patient records, reducing data input errors and improving data com-pleteness. IISs are computerized systems that:

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• Record all shots on all age groups given by all

providers in a geopolitical catchment area.

• Have functions and features needed by an

immunization program (e.g., vaccine inventory management and adverse event reporting).

• Have interoperability with other health informa -tion systems, including EHRs.

• Consolidate vaccine records into a single, elec -tronic source that helps facilitate reminder-recall systems and clinician decision support to avoid missed and unnecessary vaccinations and to reduce wasted vaccine.

ASSeSSINg VACCINe eFFeCtIVeNeSS ANd SAFety

Once a vaccine is recommended for routine use, it is essential that systems be in place to monitor the impact of the vaccine on the disease or the vaccine may not provide the level of protection needed to meet disease control objectives. For example, in the 1980s, outbreaks of measles occurred in schools that had high coverage with one dose of measles vaccine. Recognizing that a single dose of measles vaccine was not providing sufficient immunity, the ACIP recommended in 1989 that a second dose of measles vaccine be added to the

routine immunization schedule. Unexpected changes in the epidemiology of disease may also follow vac-cine introduction, such as following the introduction of PCV7, after which there was an increase in disease caused by non-vaccine serotypes that were resistant to some commonly used antibiotics.

Through its support of extramural and national pro-gram operations, the Section 317 Propro-gram contributes to the public health systems and expertise that are fun-damental to assuring that our national vaccine policies and programs have the intended impact. Public health implements several different approaches to monitor the epidemiology of VPDs. Some diseases are monitored through notifiable disease systems, which collect data at the national and state levels about diseases and condi-tions for which there is required reporting. For many conditions, laboratory-based diagnosis is essential to confirm the diagnosis, and public health laboratories at the federal and state levels provide essential sup-port for case investigation. Some VPDs are monitored through population-based laboratory reporting systems, such as the ABCs, which provided important data on the impact of PCV7 vaccination of children in the U.S. (Figure 4) and is now providing the first evidence of the impact of the additional serotypes included in the PCV13 vaccine.

Other VPDs that may not be routinely confirmed by

Figure 4. Impact of PCV7 vaccine on invasive pneumococcal disease among children <5 years of age, 1998–2009a

aPilishvili T, Lexau C, Farley MM, Hadler J, Harrison LH, Bennett NM, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis 2010;201:32-41.

PCV 5 pneumococcal conjugate vaccine

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laboratory testing are included in special sentinel sur-veillance projects. This approach has provided valuable information about the impact of rotavirus vaccines on acute gastroenteritis among young children in the U.S. Specialized molecular testing provides critical infor-mation to help determine the source of disease trans-mission when epidemiologic linkages cannot be identi-fied. For example, molecular typing data are essential to determine the source of measles and rubella cases in the U.S. and provide documentation of the elimination of endemic measles and rubella. Molecular testing also plays an important role in assessing vaccine safety. For example, genetic sequencing data have documented varicella vaccine strain virus within the cerebrospinal fluid of vaccinated individuals, supporting the hypoth-esis that varicella vaccine may rarely cause aseptic meningitis as a side effect of vaccination. In contrast, measles vaccine virus has not been isolated from the brain of people with subacute sclerosing panencephali-tis, a rare and chronic progressive inflammation of the brain caused by persistent infection of measles virus; indeed, it has been shown with molecular typing that when isolated measles viruses were analyzed, they have always been consistent with wild-type measles instead of measles vaccine virus. Such testing is only available through public health laboratories. There is no private market for such testing; therefore, the capacity must remain in the public sector.

After a vaccine is licensed and used in the U.S., public health employs several approaches to monitor vaccine safety. The Section 317 Program helps sup-port the national expertise in vaccine safety and the systems that identify and evaluate potential vaccine adverse reactions.

The Vaccine Adverse Event Reporting System (VAERS) is a national spontaneous reporting system that is jointly managed by CDC and the FDA. Certain reports are mandatory, but anyone can report any adverse event to VAERS. Although VAERS reports alone rarely can establish causality, and the limitations of the system are significant, the system has helped prompt investigations that ultimately identified serious adverse events. Safety is also assessed by special studies that are organized and funded by CDC, FDA, or the vaccine’s manufacturer. Since 1992, the Vaccine Safety Datalink (VSD), a consortium of managed care organizations with access to electronic data files on both immuniza-tion and various health outcomes, has provided critical infrastructure for vaccine safety studies in the U.S. In recent years, VSD investigators have developed new methods for more rapid approaches to evaluate safety through ongoing review of accrued data for speci-fied diagnoses during specispeci-fied intervals following a

specified vaccine. This approach, called rapid cycle analysis (RCA), has been used to evaluate the safety of a number of newer vaccines. For example, RCA identified an increased risk of febrile seizures following the combined measles-mumps-rubella-varicella vaccine among children aged 12–23 months compared with the separate administration of measles-mumps-rubella and varicella vaccines in this age group.

Data collected also allow the risks of adverse events following immunization to be reviewed in the context of the benefits provided by the vaccine. Data on adverse events may lead to recommendations for additional information to be provided prior to vaccination, changes in the vaccine recommendation, or even the withdrawal of recommendations for use of a vaccine. Post-licensure monitoring of vaccine safety

Vaccine safety begins at product development before a vaccine is licensed and continues after licensure to make sure uncommon potential adverse events are identified. If a significant safety event occurs, measures are taken to respond, including suspending the use of and/or withdrawing a product from the market. Such an event occurred in the late 1990s.

In 1998, the first pediatric rotavirus vaccine (RotaShield®, Pfizer, New York, New York) was licensed to protect infants and young children from severe acute gastroenteritis (i.e., vomiting and severe diarrhea) caused by rotaviruses. This vaccine became linked to a condition called intussusception among vaccinated infants, which is a blockage or twisting of the intestines that sometimes requires surgery and can be fatal. Although five cases of intussusception were noted in pre-licensure studies of RotaShield, it was not clear that this incidence was in excess of what would be expected to occur naturally. This information was included in the product labeling when the vaccine was approved, and a code was established to allow specific report-ing of this condition to VAERS. By May 21, 1999, 10 cases were identified among infants who had received RotaShield in the U.S.; six of these cases occurred within three to six days following vaccination. In June 1999, CDC initiated a multistate case-control study.26 By July 7, 1999, 15 cases among recipients of rotavirus vaccine had been reported to VAERS; of these, 12 had developed intussusception within one week of vaccina-tion. Additional data from a manufacturer-sponsored post-licensure study and preliminary data from the CDC case-control study became available in early July 1999. On July 16, 1999, CDC announced a suspen-sion of the use of RotaShield pending completion of ongoing studies.27 Both the CDC case-control study and a large linked database study were completed by

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October 1999 and confirmed an approximately 30-fold increase in risk of intussusception following the first dose of RotaShield. In October 1999, the manufacturer voluntarily withdrew the product from the market and the ACIP withdrew its recommendation for the use of RotaShield in the U.S.28

More recently, two new rotavirus vaccines (RotaTeq®, Merck Vaccines, West Point, Pennsylvania, licensed in 2006, and Rotarix®, GlaxoSmithKline, Philadelphia, Pennsylvania, licensed in 2008) have been licensed in the U.S. and are recommended for routine use in infants. Both vaccines were evaluated in large (more than 30,000 vaccinated infants) pre-licensure studies to evaluate the risk of intussusception, and no evidence of increased risk was found. Post-licensure studies in other countries have found about a fivefold increase of risk of intussusception following the first dose in some populations. Ongoing studies of RotaTeq in the VSD in the U.S. have found no evidence of an increase in risk; monitoring of both vaccines continues.

moNItoRINg PRogRAm PeRFoRmANCe The performance of national, state, and local immuni-zation programs is monitored through vaccine coverage assessments toward Healthy People 2020 goals.29 The public health systems and workforce funded through the Section 317 Program identify gaps in immunization coverage and guide program priorities using multiple approaches.

The National Immunization Survey (NIS), a large, random-digit-dial survey, is conducted at the national level and is used to obtain immunization coverage estimates for children aged 19–35 months. Provider-verified records are obtained and estimates are made both of national and state-specific coverage by vaccine and by several different vaccine series on an annual basis. Since 2006, the NIS has been expanded to collect data on vaccination of adolescents aged 13–17 years (NIS-Teen). NIS-Teen provides coverage estimates by vaccine and by state on an annual basis. Vaccine cov-erage among adults is monitored at the national level by the National Health Interview Survey (NHIS) and at the state level by the Behavioral Risk Factor Surveil-lance System (BRFSS). Other systems were developed during the 2009 H1N1 influenza pandemic to collect timely information on coverage. These systems include Internet panel surveys currently used to monitor influ-enza vaccine coverage among pregnant women and health-care workers, and work is ongoing to identify alternatives to telephone surveys, given their decreas-ing response rates.

In addition to these national efforts, the Section

317 Program also contributes to efforts at the state and local levels to monitor program performance. This contribution includes efforts to implement IISs that, in addition to quality assurance, can be used to monitor immunization coverage and identify communities with lower vaccine coverage. Through support from the Section 317 Program, states also monitor the impact of state vaccine requirement policies by monitoring vaccine coverage at school entry and exemption rates. ReSPoNdINg to PuBlIC

HeAltH emeRgeNCIeS

Immunization programs are regularly involved in responding to public health emergencies. These activi-ties include managing vaccine supply interruptions and shortages and responding to disease outbreaks. The flexibility of the Section 317 Program to support the immunization workforce and systems necessary for responding to such emergencies is an important feature of the program.

Manufacturing vaccines is a complex process, and it is not uncommon for supply interruptions to occur, thereby causing vaccine shortages. When vaccine short-ages occur, partners—including vaccine manufacturers, other public health officials, and medical professional societies—work with CDC to manage vaccine orders from both the private and public sectors and to control the distribution of available vaccine to assure equity between the two sectors. If available and projected vaccine supplies are not adequate to provide all rec-ommended doses of the vaccine to the population for whom it is recommended, temporary changes in rec-ommendations may be made to maximize protection while reducing demand to meet supply. During the Haemophilus influenzae type b (Hib) vaccine shortage in 2009–2010, the booster dose was temporarily halted except for certain children at increased risk of Hib dis-ease. The Section 317 Program contributes to the com-munications systems that deliver important information about vaccine supply and encourage compliance with any shortage recommendations. This system includes a CDC Web page with timely and updated information about vaccine shortages.

Public health response to VPD outbreaks is largely conducted at the local and state levels. Some diseases such as polio and measles are no longer endemic in the U.S., so every suspected case requires timely and thorough investigation, including efforts to identify where the infection was acquired and settings in which further transmission may have occurred. Responding to any outbreak is a labor-intensive and costly effort that requires epidemiologists, laboratory support,

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and extensive fieldwork. The Section 317 Program contributes to outbreak response by supporting the immunization systems and workforce at the state and local levels that actively search for cases, collect information needed to confirm the diagnosis, identify settings where disease transmission may be occurring, and follow up with all individuals who might have been exposed to implement control. The data from these investigations are essential tools in determining and guiding outbreak control strategies, such as quar-antining exposed people, providing antimicrobial or immune globulin prophylaxis, canceling public events, and guiding vaccination efforts. Public health response may also involve mass immunization efforts, such as those done for meningitis, hepatitis A, and pertussis outbreaks in recent years. The Section 317 Program contributes to the workforce and vaccine for such efforts. The flexibility of the Section 317 Program to vaccinate adults is particularly important in outbreak response.

At the national level, the Section 317 Program sup-ports efforts to document and communicate nation-ally about outbreak response and its impact, provide guidance on outbreak control, and, if invited by state health officials, initiate or enhance field investigations to support state and local public health responses. The cost of a VPD outbreak: measles

The U.S. recently experienced an increase in measles— a highly contagious disease spread through the air when an infected person coughs or sneezes. Measles is so contagious that if one person is infected, nine out of 10 people with whom they have close contact who are not immune to measles will become infected.30 Before the measles vaccine was introduced in 1963, there were about three to four million cases of measles in the U.S. alone; essentially every child had the disease by the time they were 15 years of age. About 1,000 people suffered disabilities from the disease, such as deafness or permanent brain damage from encephalitis, and approximately 450 people died each year from measles. By 2000, naturally occurring cases of measles had been eliminated.31 During 2000–2008, there were approxi-mately 50 measles cases each year that had come from other countries where measles was still endemic,32 with increasing numbers of importations into the U.S. as a result of increases in measles cases in countries visited by U.S. travelers, including some parts of Europe, Asia, the Pacific, and Africa.33

Outbreaks of measles and other VPDs can occur at any time in the U.S. In 2011, 17 measles outbreaks occurred, resulting in 222 cases of measles. Forty-four percent of the outbreak-associated cases were among

people who chose not to be vaccinated, and 90% of cases were traced to other countries with lower immunization rates. The 2011 cases marked the high-est number of cases in 15 years. The public health investment in staff and resources is significant in responding to these outbreaks. Each case of measles triggers intense public health response to prevent this highly contagious disease from spreading. Section 317 contributes to the public health expertise and workforce, systems, and strategies, such as vaccination, that are necessary to contain measles outbreaks. The following response examples highlight the investment in resources involved in supporting response efforts.

A public health response to measles in Salt Lake County, Utah, from March to April 2011 involved nine measles cases, but required officials to trace thousands of contacts, review immunization records of hospital workers and teachers, give post-exposure prophylaxis to nearly 400 people, and isolate 200 others. The esti-mated cost of this response was $300,000.

To stop a 14-person measles outbreak that began with one unvaccinated tourist visiting a U.S. hospital emergency room in Arizona in 2008, the Arizona Department of Health had to track down and interview 8,321 people, seven Tucson hospitals had to furlough staff members for a combined 15,120 work-hours, and two hospitals where patients were admitted spent $799,136 to contain the disease.

The 2008 measles outbreak in San Diego, Califor-nia, exposed 839 people, including 11 unvaccinated children who developed the disease, and resulted in the hospitalization of an infant who was too young to be vaccinated. The total cost of response was $124,517. The net public-sector cost was $10,376 per case, and the average cost to the affected families was approximately $775 per child.

oPPoRtuNItIeS

In many ways, the potential of vaccines to reach and protect the health of the public has never been greater. We have record-high childhood immunization cover-age rates and significant decreases in disease. Since 2000, 11 additional vaccines have been routinely rec-ommended for children, adolescents, or adults along with numerous recommendations for vaccine use in expanded age groups, such as the universal recom-mendation for seasonal influenza vaccine, to protect Americans from serious and life-threatening diseases. Access to immunization services is expected to improve as health insurance reforms are fully implemented, and improvements in health information technologies have the potential to create efficiencies and improve

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health-care quality. Yet, with each of these opportuni-ties come challenges that, if ignored, could undermine our success.

One challenge is a direct byproduct of our success. As we have significantly decreased the rates of most VPDs, the absence of disease has decreased public awareness about the importance of maintaining high vaccination coverage rates. The immunization infra-structure needs to be able to fully support efforts to provide the scientific evidence that underpins national immunization policies, including vaccine safety systems, and the development and dissemination of informa-tion about the benefits and potential side effects of vaccines within the context of the risks of the diseases they prevent.

New and expanded vaccine recommendations provide ever-increasing protection from serious and deadly infectious diseases. Along with this protec-tion come increased costs and crowded and complex immunization schedules. There are now new popula-tions recommended for vaccinapopula-tions and new provider groups to reach and educate. For example, public health is strengthening partnerships with medical specialties, such as obstetricians and gynecologists to improve vaccination of pregnant women, and with complementary health-care venues, such as pharma-cies and other retail clinics, to increase capacity and coverage for seasonal flu vaccination. The success of these partnerships in achieving national immunization goals relies on robust public health systems and a highly skilled public health workforce to provide outreach and education, improve collaboration among diverse providers, ensure proper vaccine storage and handling, support the use of effective immunization information technologies, and address disparities. While it has not been the only resource, the Section 317 Program has been and continues to be the core funding for these critical activities, as illustrated in the pertussis response of 2010–2012.

CASe Study: tHe Role oF

ImmuNIzAtIoN INFRAStRuCtuRe IN ReSPoNdINg to PeRtuSSIS, 2010–2012 Pertussis, also known as whooping cough, is a respira-tory infection that causes very prolonged coughing illness in most people, but can lead to pneumonia and fatal respiratory failure in infants. The disease can be cyclical, with peaks every three to five years, and the U.S. experienced a 50-year high in 2012. Most recently, large outbreaks in California and Washington State illustrate public health immunization infrastructure in action.

In 2010, California reported more than 9,000 cases of pertussis, with 10 infant deaths.34 Experiencing its worst outbreak of whooping cough in decades, Wash-ington State declared an epidemic of pertussis on April 3, 2012. As of early August 2012, Washington State had nearly 3,50035 reported cases compared with 965 cases reported statewide for all of 2011. As of August 11, 2012, 46 states and the District of Columbia reported increases in disease compared with the same time period in 2011.36 A number of efforts are under way to control these outbreaks and prevent the spread of disease; these efforts rely upon the following critical immunization program functions, which are illustrated in Figure 5.

Response to public health emergencies

During the past two years, the Section 317 Program14 has provided critical support for the public health response to the increasing number of pertussis out-breaks. The immunization systems and workforce at the state and local levels have conducted epidemiologic studies, implemented targeted vaccination campaigns, and increased public awareness and provider education activities. At the federal level, CDC has provided scien-tific expertise in pertussis; science-based communica-tion tools and resources for use nacommunica-tionwide, statewide, and locally; and Section 317-purchased vaccines for targeted campaigns. The ability of the Section 317 Pro-gram to respond to public health emergencies makes it a valuable asset in protecting the nation’s health. Communicating which vaccines are needed, and the benefits and risks

Messages about the pertussis outbreaks, the risks of serious complications and deaths among infants too young to be vaccinated, and tetanus-diphtheria-pertussis (Tdap) vaccine recommendations for adolescents and adults are delivered using a variety of technologies and venues. CDC made available science-based provider edu-cation and public awareness resources, including audio and video, social media, print materials, publications, and multimedia tools. In Washington State, the Depart-ment of Health focused its provider education efforts on diagnosing, treating, and preventing pertussis. Its public awareness efforts focused on the signs and symptoms of pertussis and vaccination recommendations, using multiple communication venues (e.g., messages on public transportation).

Improved access to immunization services

An important feature of the Section 317 Program is the flexibility in directing resources to meet priority needs, such as outbreak control, and to support public-private

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efforts to improve access to vaccination across the life span. During the 2010 pertussis epidemic in California, the Department of Public Health offered free Tdap vac-cine to birthing hospitals and local health departments to vaccinate mothers and close contacts of newborns. In Washington State, targeted efforts substantially increased Tdap vaccination among adults, with a 140% increase in adult vaccination from March 25 to May 26, 2012, compared with the same time period in 2011, resulting in 82,453 vs. 34,171 doses administered in 2012 vs. 2011, respectively. Washington State was also able to use its Section 317 vaccine funding to allocate an additional 27,000 doses of Tdap vaccine to reach uninsured adults.

Developing an evidence-based immunization policy Upon review of new data about the incidence of per-tussis and the populations affected, the ACIP updated and expanded its recommendations for the use of Tdap vaccines among adolescents and adults to reduce the transmission of pertussis to infants.37

Assuring quality of immunization services

Vaccines need to be stored in the right equipment at the right temperature to ensure the most protection.

The Section 317 Program supports efforts to help pro-viders store, handle, and use vaccines for the best public health impact. For example, during an anticipated shortage of one pertussis-containing vaccine during the summer of 2012, CDC provided guidance on the use of the available pertussis-containing products to ensure their patients were fully vaccinated.38

Assessing vaccine effectiveness and safety

An effective outbreak response controls the outbreak and provides data and information to help prevent future outbreaks, including data and information that can lead to better and more effective vaccines and recommendations. CDC and Washington State are undertaking a number of efforts to evaluate strate-gies to prevent pertussis, including assessments of the effectiveness of maternal and caregiver vaccination in protecting infants, and the duration of protection provided by the vaccine given to adolescents. This information is valuable in informing and evaluating immunization recommendations.

Monitoring program performance

Vaccination coverage is monitored and reported through the NIS, the BRFSS, and the NHIS. This

Figure 5. Role of Section 317 Immunization Program funding in preventing infectious disease: pertussis case study, 2010–2012

Section 317

funding

Critical functions of immunization programs develop evidence-based immunization policy

Communicate which vaccines are needed, and the benefits and risks

Improve access to immunization servicesa

Assure quality immunization services

Assess vaccine effectiveness and safety monitor program performance Respond to public health emergenciesa

Control

current

and

prevent

future

pertussis

outbreaks

aSection 317 funds can be used to purchase vaccine ACIP 5 Advisory Committee on Immunization Practices Tdap 5 tetanus-diphtheria-pertussis vaccine

CDC 5 Centers for Disease Control and Prevention

Updated ACIP recommendations for Tdap

Public awareness and provider education to increase vaccination, timely diagnosis,

and treatment

Vaccination campaigns; partnerships with complementary venues Guidance during shortage of one

pertussis-containing product Vaccine effectiveness studies in California and Washington State Disease surveillance and vaccine

coverage assessments State and local epidemic responses; CDC scientific, communications, and

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information has been used to identify gaps in vaccina-tion coverage to inform targeted pertussis vaccinavaccina-tion campaigns and increase public awareness and provider education efforts. It is also contributing to pertussis vaccine effectiveness studies.

CHAlleNgeS

While expanded coverage provisions of the ACA pro-vide unprecedented access to immunizations, they also have the potential to place greater stresses on the existing immunization infrastructure. Although the health insurance reforms of the ACA, when fully implemented, will improve access to clinical preventive services by improving payment for vaccines and their administration, the essential public health functions that make vaccination possible are not addressed by the ACA.

Some communities may not currently have enough in-network providers to assure access to immunization services across the life span that are now afforded through the health insurance reforms of the ACA. The role of public health in recruiting and training robust networks of in-network vaccine providers will be essential in realizing the potential of the ACA health insurance reforms. However, this training will require public health to forge new and expanded partnerships with employers, health insurance plans, and health-care providers.

The ACA also increases the visibility and role of the ACIP recommendations in determining health-care coverage policies, making it more important than ever that the ACIP has the capacity to make timely and transparent recommendations. The public health systems and workforce that monitor disease, vaccine effectiveness, and safety will become even more essen-tial in the new and evolving health-care landscape to support the work of the ACIP.

Improved health information technologies give us the opportunity to increase vaccination coverage rates as well as promote efficiency and improve qual-ity of care. However, this field is rapidly changing and evolving and spans multiple sectors of the health-care delivery system. It is critical that the public health invest-ments in health information technologies be strategic, coordinated, and standardized to the greatest extent possible to achieve efficiencies and improve quality of care. Expertise has already been developed and is held in the immunization workforce as described previously, but the demands on this knowledge base will grow immensely and must be supported.

Finally, the evolving health-care landscape may call into question the continued relevance of the Section

317 Program to the immunization enterprise. This questioning would be a severe error in judgment. For nearly 50 years, the Section 317 Program has been directed toward filling gaps in the national immu-nization program through its authorities to provide operations funding to states; to support vaccine-related epidemiology, laboratory, program, and communica-tions efforts; and to purchase vaccines for children, adolescents, and adults. For the past 20 years, the con-tribution of the Section 317 Program in providing vac-cines to underinsured children who are not eligible for VFC Program vaccines has been the most visible aspect of the program, leaving the vital contributions of the Section 317 Program to immunization infrastructure and the workforce largely unknown among decision makers and the public. While the Section 317 Program will continue to be an important resource in provid-ing a vaccine safety net for uninsured Americans39 and a flexible resource for provision of vaccines when responding to disease outbreaks and urgent needs, it is the Section 317 systems and workforce described in this report that provide the backbone for the U.S. immunization program, regardless of the payer of the vaccine given. Educating decision makers and the public about the need for a strong immunization infra-structure may in fact be one of our greatest challenges and our greatest opportunities. If we fail, we risk the erosion of a sound and trusted immunization system that has contributed to historic improvements in public health. If we succeed, we have the potential to transition and strengthen our immunization infrastructure and performance to realize the full potential of vaccines across the life span for millions of Americans today and well into the future.

CoNCluSIoNS ANd ReCommeNdAtIoNS Conclusion 1

Vaccination is one of our most important public health tools for directly protecting individuals from infectious diseases and indirectly protecting those who cannot be vaccinated, such as those with medical contraindica-tions, those who are too young to be vaccinated, or those with compromised immune systems. This indi-rect effect, termed “herd or community immunity,” is achieved when high vaccination coverage rates stop the transmission of disease from person to person, so that those remaining unvaccinated are protected from exposure to the infectious agent. Achieving high population coverage rates cannot be accomplished with vaccine alone.

The Section 317 Program supports the public health systems and workforce at the local, state, and national

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